跳至主要内容
临床试验/NCT06240572
NCT06240572招募中不适用

Development and Validation of a Natural Language Processing Tool to Enable Clinical Research in Emergency and Acute Care Medicine: Retrospective Cohort Study

Mario Negri Institute for Pharmacological Research12 个研究点 分布在 1 个国家目标入组 300,000 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300,000
试验地点
12
主要终点
Concordance in filling in the virtual case report form

研究概览

简要总结

The goal of this retrospective cohort study is to develop and validate a language model that can interpret the contents of emergency department electronic medical records and extract relevant information for research purposes in all adult patients who arrived at the participating emergency departments in a three-year period.

The main question it aims to answer is: is the language model able to interpret the contents of emergency department electronic medical records and extract the requested information from them so that it can be used to make accurate analyses and predictions?

The study is retrospective and data will be extracted automatically from the medical health records.

详细描述

BACKGROUND AND RATIONALE FOR THE STUDY

Conducting clinical and quality-of-care assessment research in emergency medicine is as difficult as it is important. It is difficult because the vast number of patients that need to be treated and the chronic shortage of staff make ad hoc data collection impractical. It is important because, in the end, research enables emergency physicians and nurses to base their practice on evidence obtained in their own, unique setting, as opposed to evidence obtained in far-removed contexts, as is commonly the case today.

The only way to bridge the gap between research needs and availability of robust data is to extract data directly from the electronic health records (EHRs) of emergency departments, avoiding dedicated, time-consuming data collection. This is a difficult task, however, because the most useful information is in free text format (e.g., presence of signs and symptoms, suspected and confirmed diagnosis, anamnesis). Such circumstances and needs require a reliable natural language processing (NLP) tool to derive highly consistent data from free text.

Today, large-scale language models are available that can accurately interpret natural language. These models are trained on huge amounts of general knowledge taken mostly from the Internet, however, so their performance in more specialized areas, such as the medical domain, may not be optimal.

The present study is part of a larger project called eCREAM (enabling Clinical Research in Emergency and Acute-care Medicine), and aims to develop and validate a language model (called eCREAM_LM) for six languages that can interpret the contents of emergency department EHRs and extract relevant information for research purposes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Arrived at emergency department between 1 January 2021 and 31 December 2023

排除标准

  • 未提供

研究组 & 干预措施

Adults who attended the emergency department

干预措施: no intervention (Other)

结局指标

主要结局

Concordance in filling in the virtual case report form

时间窗: 1 month

Level of concordance in filling in the virtual case report form between the expert physicians and the eCREAM\_LM language model

次要结局

未报告次要终点

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (12)

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